Labor Induction With Misoprostol Versus Oxytocin in Women With Premature Rupture of Membranes

NCT ID: NCT04143685

Last Updated: 2020-01-29

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-01
• Study Completion Date: 2021-10-01

Brief Summary

This study compares the rate of vaginal delivery after induction of labor with misoprostol versus oxytocin in women with prelabor rupture of membranes. Participants will be randomized to receive either oral misoprotsol every four hours until going into labor, or intravenous oxytocin in increasing dose.

Detailed Description

Misoprostol is a synthetic prostaglandin analogue commonly used for labor induction. It causes uterine contractions and ripening of the cervix. Oxytocin sold under the brand name Pitocin among others, is a medication made from the peptide oxytocin and is used to cause contraction of the uterus to start labor.

This randomized controlled trial will compare induction of labor in women with term premature rupture of the membranes and unripe cervix using misoprostol versus oxytocin. The primary outcome is the rate of vaginal delivery. Secondary outcomes will include cesarean section rate, time interval from induction of labor to delivery, neonatal morbidity, patient satisfaction and side effects, as well as chorioamnionitis.

Conditions

Prelabor Rupture of Membranes; Premature Rupture of Membrane

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

misoprostol

misoprostol 50 mcg tablet by mouth every four hours for maximum dosage of six

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Oral administration of cytotec every 4 hours until a maximum of 6 doses

oxytocin

Oxytocin 10 IU in 1000 mL Standard solution. Starting with 10 mL/hr infusion rate and increasing by 10mL/hr every 20 minutes until achieving 3-5 regular uterine contractions every 10 minutes (as recorded by cardiotocography)

Group Type: ACTIVE_COMPARATOR

Oxytocin

Intervention Type: DRUG

Intravenous infusion of Pitocin through an IVAC until delivery

Interventions

Misoprostol

Oral administration of cytotec every 4 hours until a maximum of 6 doses

Intervention Type: DRUG

Oxytocin

Intravenous infusion of Pitocin through an IVAC until delivery

Intervention Type: DRUG

Other Intervention Names

Cytotec; PGE1; Pitocin

Eligibility Criteria

Inclusion Criteria

• Women in their 1st - 4th delivery
• Term prelabor rupture of membranes (37+0 to 42+0 gestational age)
• Vertex presentation
• Singleton pregnancy

Exclusion Criteria

• Multiple pregnancy
• Previous cesarean section
• Chorioamnionitis on admission
• >2 symptomatic uterine contractions in 10 minutes
• Prostaglandins hypersensitivity
• Contraindication for vaginal delivery

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

sammour.rami

OTHER_GOV

Sponsor Role: lead

Responsible Party

sammour.rami

Head of Obstetrics

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bnai Zion Medical Center

Haifa, , Israel

Site Status: RECRUITING

Countries

Israel

Facility Contacts

Rami Sammour, MD

Role: primary

rsammour2002@gmail.com

+97248359052

Other Identifiers

MISOX-001

Identifier Type: -

Identifier Source: org_study_id